Efficacy and Safety of Palonosetron Hydrochloride in the Prevention of Nausea and Vomiting
NCT ID: NCT01481831
Last Updated: 2012-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
599 participants
INTERVENTIONAL
2011-07-31
Brief Summary
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Detailed Description
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Group II (Moderately Emetogenic Chemotherapy): Patients that accepted chemotherapy including any dose of Carboplatin, Daunorubicin, Oaliplatin, Irinotecan, or Doxorubicin\<60mg/m2(not include liposomal doxorubicin), Epirubicin≤90mg/m2, Carmustine≤250mg/m2, Methotrexate≥250mg/m2, Cyclophosphamide≤1500mg/m2, Arabinoside\>200mg/m2, IFO\<10g/m2, Cisplatin≥50mg/m2.
Total subjects: 1000, single dose of palonosetron group of 500 patients, repeated doses of palonosetron group of 500 patients. According to the study subjects receiving highly emetogenic chemotherapy or moderately emetogenic chemotherapy, subjects are stratified randomize.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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H PALO day 1
Highly Emetogenic Arm, Palonosetron 0.25mg IV\*1 dose on day 1
Palonosetron Hydrochloride
0.25 mg IV\*1 dose on day 1, 30 minutes prior to the administration of the major chemotherapeutic agent.
H PALO day 1,3,5
Highly Emetogenic Arm, Palonosetron 0.25mg IV\*3 doses on days 1,3 and 5
Palonosetron Hydrochloride
0.25mg IV\*3 doses on days 1,3 and 5,30 minutes prior to the administration of the major chemotherapeutic agent.
M PALO day 1
Moderately Emetogenic Arm, Palonosetron 0.25mg IV\*1 dose on day 1
Palonosetron Hydrochloride
0.25 mg IV\*1 dose on day 1, 30 minutes prior to the administration of the major chemotherapeutic agent.
M PALO day 1,3,5
Moderately Emetogenic Arm, Palonosetron 0.25mg IV\*3 doses on days 1,3 and 5
Palonosetron Hydrochloride
0.25mg IV\*3 doses on days 1,3 and 5,30 minutes prior to the administration of the major chemotherapeutic agent.
Interventions
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Palonosetron Hydrochloride
0.25 mg IV\*1 dose on day 1, 30 minutes prior to the administration of the major chemotherapeutic agent.
Palonosetron Hydrochloride
0.25mg IV\*3 doses on days 1,3 and 5,30 minutes prior to the administration of the major chemotherapeutic agent.
Eligibility Criteria
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Inclusion Criteria
2. The concrete chemotherapy plan does not limited, group I (Highly Emetogenic Chemotherapy), group II (Moderately Emetogenic Chemotherapy);
3. Male or female aged 18-75 years, ECOG≤2, estimates survival time≥3 months;
4. WBC≥3.0×109/L, ANC≥1.5×109/L, PLT≥80×109/L, total bilirubin≤1.5×ULN(Normal value upper limit), AST and ALT≤2.5×ULN(With transferability liver cancer≤5×ULN), Cr and BUN≤1.5×ULN, electrolyte and electrocardiogram are normal, conforms to the chemotherapy adaptation;
5. Patients have been apart from the previous chemotherapy to finish above 2 weeks (including 2 weeks);
6. Patients that voluntarily sign the consent form.
Exclusion Criteria
2. Patients have accepted any radiotherapy during the experimental period;
3. Gastric outlet or intestinal obstruction;
4. Patients have serious heart diseases, liver kidney diseases, or metabolism function disorder;
5. Patients have epilepsy, or have been used psychotropic drug and calm drug;
6. Received any drugs with potential anti-emetic efficacy, or experienced any vomiting, nausea or retching in the 24 hours prior to chemotherapy;
7. Patients with transferability brain tumor, have vomiting caused by skull high pressure, or can not speak sickness situation and adverse reactions by self;
8. Patients have known hypersensitivity to 5-HT3 antagonists;
9. Patients have chemotherapy contraindications;
10. Patients are participating, or have participated in other Clinical studies of new drugs within 2 weeks.
18 Years
75 Years
ALL
No
Sponsors
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JiangSu Chia-Tai Tianqin Pharmacy Co.Ltd
UNKNOWN
Shanghai Changzheng Hospital
OTHER
Responsible Party
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Zhan Wang
Principal Investigator
Locations
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Anhui Provincial Hospital
Hefei, Anhui, China
Chinese Academy of Medical Sciences Cancer Hospital
Beijing, Beijing Municipality, China
Chinese PLA 301 Hospital
Beijing, Beijing Municipality, China
Chinese PLA 307 Hospital
Beijing, Beijing Municipality, China
Chinese PLA Navy General Hospital
Beijing, Beijing Municipality, China
Fuzhou General Hospital of Nanjing Military Command
Fuzhou, Fujian, China
Guangxi Cancer Hospital
Nanning, Guangxi, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
The First People's Hospital of Changzhou
Changzhou, Jiangsu, China
Nanjing General Hospital of Nanjing Military Command
Nanjing, Jiangsu, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
The Fourth People's Hospital of Wuxi
Wuxi, Jiangsu, China
Shandong Cancer Hospital
Jinan, Shandong, China
Shandong Provincial Hospital
Jinan, Shandong, China
The Affiliated Hospital of Medical College Qingdao University
Qingdao, Shandong, China
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China
Shanghai Xinhua Hospital
Shanghai, Shanghai Municipality, China
Tangdu Hospital of Fourth Military Medical University
Xian, Shanxi, China
Countries
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Other Identifiers
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zhiruo
Identifier Type: -
Identifier Source: org_study_id